Quality Assurance Specialist

6 days ago

Kent, United Kingdom SRG Full time

Job Overview

Quality Assurance Specialist

About the Role

  • Collaborate with stakeholders to oversee the progression and timely execution of quality assurance activities, ensuring seamless integration with business objectives.
  • Manage deviations, investigations, and corrective actions, applying expertise in regulatory compliance and industry best practices.
  • Oversee the documentation system, including reviewing and approving standard operating procedures, batch manufacturing records, and other controlled documentation, ensuring accuracy and compliance.
  • Evaluate site compliance and implement improvements through internal audits, driving continuous quality enhancement.

Key Responsibilities

  • Develop and implement quality assurance strategies, aligning with business goals and regulatory requirements.
  • Collaborate with cross-functional teams to ensure effective quality management, including process validation, cleaning validation, and verification.
  • Manage validation lifecycles from creation to retirement, ensuring compliance and efficiency.
  • Provide expert guidance on equipment, facility, and process change management, ensuring minimal disruption to operations.
  • Develop and maintain strong relationships with stakeholders, including vendors and suppliers, to ensure quality standards are met.

Requirements

  • Proven experience in quality assurance within a pharmaceutical or related industry.
  • Expertise in process validation, cleaning validation, and verification, with a strong understanding of regulatory requirements.
  • Experience working on sterile sites, with a focus on quality assurance and regulatory compliance.
  • Strong communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.
  • Ability to manage multiple priorities, meet deadlines, and prioritize tasks accordingly.
  • Excellent attention to detail and high standards in all work output.

About SRG

SRG is a dynamic and ambitious company, dedicated to delivering exceptional results in the clinical trial manufacturing sector. As a Quality Assurance Specialist, you will play a critical role in driving quality enhancement and regulatory compliance, while contributing to the company's growth and success.

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